Retention of Signed Informed Consent Forms

As described in the UF Research Records Retention page of this website, and under HHS regulations at45 CFR 46.115(b), an investigator must maintain certain records (e.g., informed consent documents signed by subjects) on behalf of the institution for a minimum of 3 years after completion of the research for those studies not requiring a HIPAA authorization and 6 years after completion of the research for those studies requiring a HIPAA authorization Consent forms for FDA-regulated studies should be retained in accordance with the sponsor agreement.